Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
75
Countries
5
Sites
9
Small Cell Lung Cancer and Neuroendocrine Carcinoma
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Feb 2024 → 5 Mar 2025
- Decision date (initial)
- 2023-11-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Small Cell Lung Cancer and Neuroendocrine Carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10041067 | Small cell lung cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Head of CTRM Clinical Trial Regulatory Management, Product Development Regulatory
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Head of CTRM Clinical Trial Regulatory Management, Product Development Regulatory
Locations
5 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 4 | 1 |
| France | Ended | 8 | 2 |
| Germany | Ended | 8 | 2 |
| Poland | Ended | 4 | 1 |
| Spain | Ended | 12 | 3 |
| Rest of world
Japan, United States
|
— | 39 | — |
Investigational sites
Rigshospitalet
Rigshospitalet; Fase 1 Enhed - Onkologi, Blegdamsvej 9, 2100, Copenhagen Oe
Centre Leon Berard
Oncologie Thoracique, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Universitaetsklinikum Essen AöR
Innere Klinik (Tumorforschung) WTZ-Ambulanz, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Heidelberg AöR
National Center for Tumor Diseases (NCT) Heidelberg, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Uniwersyteckie Centrum Kliniczne
Ośrodek Badań Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2024-02-20 | 2024-03-04 | 2024-08-02 | ||
| Poland | 2024-02-29 | 2024-03-07 | 2024-08-02 | ||
| Spain | 2024-03-07 | 2024-03-15 | 2024-08-02 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 3 · Art. 38 CTR
Temporary halt TH-39841
- Halt date
- 2024-08-02
- Member states concerned
- Denmark
- Publication date
- 2024-08-09
- Reason
- Sponsor decision
- Explanation
- To collect and analyse the data from the currently enrolled patients in the study in order to understand whether any changes in the study conduct are necessary.
- Follow-up measures
- The patients allocated to the upcoming DE cohorts will receive treatment (see below for dose proposal). Patients already enrolled in the study can continue to receive study treatment as planned. The Sponsor will continue to organize safety calls with investigators and share regular updates.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-39845
- Halt date
- 2024-08-02
- Member states concerned
- Spain
- Publication date
- 2024-08-09
- Reason
- Sponsor decision
- Explanation
- To collect and analyse the data from the currently enrolled patients in the study in order to understand whether any changes in the study conduct are necessary.
- Follow-up measures
- The patients allocated to the upcoming DE cohorts will receive treatment (see below for dose proposal). Patients already enrolled in the study can continue to receive study treatment as planned. The Sponsor will continue to organize safety calls with investigators and share regular updates.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-39843
- Halt date
- 2024-08-02
- Member states concerned
- Poland
- Publication date
- 2024-08-09
- Reason
- Sponsor decision
- Explanation
- To collect and analyse the data from the currently enrolled patients in the study in order to understand whether any changes in the study conduct are necessary.
- Follow-up measures
- The patients allocated to the upcoming DE cohorts will receive treatment (see below for dose proposal). Patients already enrolled in the study can continue to receive study treatment as planned. The Sponsor will continue to organize safety calls with investigators and share regular updates.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-10 | Denmark | Acceptable with conditions 2023-11-27
|
2023-11-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-13 | Denmark | Acceptable 2024-01-24
|
2024-01-25 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-21 | Denmark | Acceptable 2024-06-10
|
2024-06-10 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-22 | Denmark | Acceptable 2024-06-10
|
2024-07-22 |